Kornimate/medical-research-clean huggingface dataset:
the effect of meal composition on blood lipids

Conditions: Dyslipidemia

Summary: the purpose of this study is to see if a high-protein meal leads to a better postprandial (after a meal) blood lipid profile compared to a high-monounsaturated meal.

the effect of a high-protein diet compared to a high-monounsaturated fat diet on fasting lipids is controversial (1,2), in addition, these studies did not examine the effect of a high-protein compared to a high-monounsaturated meal on postprandial lipid concentrations. postprandial lipid responses are important to examine since they are associated with heart disease (3,4). in addition, most individuals in western countries are in a postprandial state for majority of the day. the present study will compare the effect of a high-protein meal versus a high-monounsaturated fat meal on postprandial lipid responses.

Eligibility criteria:
inclusion criteria: * men and women ages 18-65 years. exclusion criteria: * use of medications or supplements that affect lipid levels, body weight, or blood glucose, * following a weight loss diet, * being a vegan, * smoking, * heavy alcohol use, * pregnancy, * lactation, * severe depression, * eating disorders, * presence of liver, kidney, gastrointestinal, adrenal, or untreated thyroid disease, * diabetes, * lactose intolerance, * documented mal-absorption, or * bowel surgery that affects absorption.
a phase 3 clinical study of kw-3357 in patients with dic

Conditions: Disseminated Intravascular Coagulation (DIC)

Summary: to evaluate the efficacy and safety of kw-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (dic) by japanese association for acute medicine-defined dic criteria.


Eligibility criteria:
inclusion criteria: * japanese association for acute medicine-defined dic criteria score \>= 4 * antithrombin activity \<= 70% * written informed consent from patient or guardian exclusion criteria: * anamnesis or complication of serious drug allergy * serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis * pregnant, nursing, or possibly pregnant woman * possibility for the promotion of bleeding by concomitant use of heparin
the ai-cac model for subclinical atherosclerosis detection on chest x-ray

Conditions: Cardiovascular Diseases; Atherosclerosis; Coronary Artery Calcification

Summary: the ai-cac model is an artificial intelligence system capable of assessing the presence of subclinical atherosclerosis on a simple chest radiograph. the present study will provide prospective validation of its diagnostic performance in a primary prevention population with a clinical indication for coronary artery calcium (cac) testing.

the ai-cac-pvs project is a prospective, multicenter, single-arm clinical study, with enrollment at 5 radiology units in piedmont (italy). consecutive individuals without prior reported cardiovascular events referred for a non-contrast chest ct for the assessment of coronary artery calcium (cac) score for cardiovascular risk stratification purposes will be considered for inclusion in the study. individuals who agree to participate in the study will undergo a standard chest radiograph, as the only deviation from clinical practice. the cac score will be calculated on chest ct scans according to international standards, and the result will be provided to the patient. any subsequent changes in behavioral habits, lipid-lowering, antiplatelet, antihypertensive, and antidiabetic therapies prescribed by the attending physician will be collected in a dedicated dataset, along with the occurrence of cardiovascular events at the last available follow-up. the ai-cac model will be applied to the chest radiograph, yielding an ai-cac value as output. the patient, radiologist, and attending physician will not be informed of the ai-cac value until the end of the study. the primary outcome will be the accuracy of the ai-cac model to detect the presence of subclinical atherosclerosis on chest x-ray as compared to the ct scan (i.e. cac \>0). the ability to predict clinical outcomes at follow-up (ascvd, atherosclerotic cardiovascular disease events comprising myocardial infarction, ischemic stroke, coronary revascularization and cardiovascular death) will be assessed as exploratory secondary outcome.

Eligibility criteria:
inclusion criteria: * consent to participate in the study * age between 40 and 75 years * clinical indication from the treating physician to undergo chest ct for cac score evaluation exclusion criteria: * prior cardiovascular events (myocardial infarction, coronary revascularization, transient ischemic attack, stroke, symptomatic peripheral vascular disease, arterial revascularization of peripheral districts) * cancer or other chronic diseases with an estimated prognosis of less than five years * technical contraindications to the execution of chest ct with electrocardiographic gating (highly penetrant atrial fibrillation, frequent ventricular extrasystoles)

Keywords: coronary artery calcium chest x-ray atherosclerotic cardiovascular disease primary prevention risk prediction artificial intelligence
phase ii trial of neoadjuvant treatment and minimal invasive surgery for esophageal and gej cancer

Conditions: Esophageal Cancer; Induction Chemotherapy

Summary: phase ii trial of induction chemotherapy with carboplatin auc 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cgy in 25 fractions plus carboplatin auc=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive surgery after 6 to 10 weeks. a pet scan will be performed at the time of randomization and 14 days after de first cycle to determine the relation between metabolic response and survival.

phase ii trial of induction chemotherapy with carboplatin auc 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cgy in 25 fractions plus carboplatin auc=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive surgery after 6 to 10 weeks. a pet scan will be performed at the time of randomization and 14 days after de first cycle to determine the relation between metabolic response and survival. the primary endpoint is to the evaluate the number of complete pathologic response. the secondary endpoints are evaluation of toxicity, radiologic response, metabolic response, results of the minimally invasive surgery (blood lost, number of conversion to open surgery, type of resection, r0, 1 or 2, post-op complications, time of hospitalization, 30 day post-op mortality), evaluate the viability of treatment protocol (number of patient that complete the phases), evaluate quality of life during the treatment and after the surgery. inclusion criterias are: histologically proven adenocarcinoma or squamous cell carcinoma of the middle and lower third of the esophagus (included tumors located in the gastro-esophageal junction siewert i and ii), age between 18 and 75 years, performance status 0 or 1, neutrophils count \> 1500/mm3, platelets count \> 100.000/mm3, hemoglobin count \> 9 g/dl, preserve hepatic and renal function, stage (tnm ajcc 7th edition): ct1b-3, n0-1, m0, signature of the informed consent. exclusion criterias are: history of another cancer, except skin non melanoma, pregnancy or history of hypersensitivity to the study drugs

Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma or squamous cell carcinoma of the middle and lower third of the esophagus (included tumors located in the gastro-esophageal junction siewert i and ii) * age between 18 and 75 years * performance status 0 or 1 * stage (tnm ajcc 7th edition): ct1b-3, n0-1, m0 exclusion criteria: * history of another cancer, except skin non melanoma * pregnancy * history of hypersensitivity to the study drugs
quality of life of patients with locally advanced and metastatic prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate possible changes in quality of life related to health (hrql) in locally advanced and metastatic prostate cancer patients, after one year of follow-up.


Eligibility criteria:
inclusion criteria: * men ≥ 18 years old * symptomatic prostate cancer patients who present symptoms due to prostate cancer disease * capacity to comply with the protocol * patient with an expected survival \> 12 months exclusion criteria: * patients who are also participating in any other clinical study * patient with other malignant diseases, apart from prostate cancer
the effect of superficial cervical plexus block on postoperative recovery quality and pain in anterior cervical spinal surgery

Conditions: Postoperative Pain

Summary: the effect of superficial cervical plexus block on postoperative recovery quality and pain in anterior cervical spinal surgery

the study was designed as a double-blind, prospective randomized controlled trial. blindness; the healthcare professionals who will monitor the patient's pain in the post-operative period will not know whether the superficial cervical plexus block is applied to the patients. randomization of the patients was planned using computer aided. it is envisaged that 20 participants will be included in the patient group that will have a superficial cervical plexus block and will not have a superficial cervical plexus block. the current pain status in the postoperative period in the patient groups that will or will not have a superficial cervical plexus block is determined by nrs (numerical rating scale) at rest and in motion at certain hour intervals ( 30.min,1.,6.,12.,24. hours) will be done, when the patients' nrs scores are 4 and above, an additional intravenous analgesic will be administered, and the number of bolus doses with pca in the first 24 hours will be recorded. the quality of recovery (qor-40) scoring system will be evaluated at the postoperative 24th hour of both patients with and without superficial cervical plexus block. in addition, the hemodynamic values of the patients will be recorded in these intervals.

Eligibility criteria:
inclusion criteria: * patients undergoing lumbar spinal surgery under elective conditions * asa i-iii * between 18-75 ages exclusion criteria: refuse during registration * request to be dismissed from study * failure to give informed consent * emergency surgery * bleeding diathesis * presence of contraindications to the la agents used in this study chronic use of opioids psychiatric disorders the presence of infection at the injection site

Keywords: recovery quality postoperative pain superficial cervical block cervical block
the development of an in-vitro system to identify gynecologic cancer cells during surgical procedures

Conditions: Gynecological Malignancies

Summary: the purpose of this study is to examine the efficacy of mid-infrared spectroscopy together with attenuated total reflection (atr), for the detection of gynecological malignancies in real time during surgery.


Eligibility criteria:
inclusion criteria: * women with one or more tumors in reproductive system exclusion criteria: * pregnant women * unable to give consent
respiratory muscle stretching for improving chest expansion and dyspnea in post-tuberculosis bronchiectasis

Conditions: Bronchiectasis Post-Tuberculosis Lung Disease

Summary: this study intends to examine the effectiveness of adding rms to a traditional program of pulmonary rehabilitation regarding chest expansion, dyspnea, and cough symptoms in bronchiectasis post-tuberculosis patients. bronchiectasis, resulting from tuberculosis treatment, is characterized by restricted chest wall motility, chronic dyspnea, and an irritating cough, factors that severely impair these patients' quality of life. it is assumed that rms improves the compliance of the chest wall, thereby enhancing respiratory mechanics and consequently reducing symptoms. the outcomes will be compared between two groups: one group with standard pulmonary rehabilitation and another group with additional rms exercises.

bronchiectasis involves the irreversible dilation and damage of the bronchi, forming an important long-term sequela in patients who have completed treatment for lung tuberculosis. this condition leads to restricted chest expansion, severe shortness of breath, and chronic cough, causing considerable distress to the affected patients' quality of life. pulmonary rehabilitation, through aerobic exercise and breathing techniques such as pursed lip breathing (plb) and the active cycle of breathing technique (acbt), has shown benefits in managing these symptoms. the potential additional benefit of exercises involving accessory respiratory muscles to improve chest wall mobility, using respiratory muscle stretching (rms) exercises, has not been well-explored. this single-blind randomized controlled trial will compare the effects of standard pulmonary rehabilitation alone versus standard rehabilitation combined with rms exercises in patients with bronchiectasis post-tuberculosis. outcomes will focus on changes in chest expansion, dyspnea, cough symptoms, and lung function parameters such as fev1, fvc, and fev1/fvc ratio. the study will involve 48 participants who meet the inclusion criteria and will run for four weeks.

Eligibility criteria:
inclusion criteria: * age 18-65 years * history of lung tb treatment * clinical or radiological diagnosis of bronchiectasis * mmrc dyspnea scale grade 1-3 exclusion criteria: * pneumothorax * pleural effusion * covid-19 * lung malignancy * chronic obstructive pulmonary disease * neuromuscular disease
beatris study: a study of adherence to bonviva (ibandronate) once monthly in women with post-menopausal osteoporosis

Conditions: Postmenopausal Osteoporosis

Summary: this 2 arm study will assess the impact of bone marker feedback (bmf), using blood sampling and communication of the results at 2 months, on adherence to monthly bonviva (150mg po) in women with post-menopausal osteoporosis. patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. the study will also assess patient satisfaction with treatment with once monthly bonviva. the anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * ambulatory post-menopausal women with osteoporosis; * 55-85 years of age; * eligible for bisphosphonate treatment; * naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake \> 6 months ago). exclusion criteria: * inability to stand or sit in an upright position for at least 60 minutes; * inability to swallow a tablet whole; * hypersensitivity to bisphosphonates; * administration of any drug, or presence of active disease, known to influence bone metabolism; * uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism; * history of major upper gastrointestinal disease.
inpatient blood glucose control in taichung veterans general hospital

Conditions: HYPERGLYCEMIA

Summary: this study will be conducted in the ward of taichung veterans general hospital. the patient with hyperglycemia in hospitalization will be enrolled by glucose management team.

this study will be conducted in the ward of taichung veterans general hospital. the type 2 diabetic patient with hyperglycemia in hospitalization are candidates. the glucose will be controlled using the insulin protocal based on the glucose monitor systems. we will assess the effects of insulin protocal and glucose monitor system on the inpatient with hyperglycemia.

Eligibility criteria:
inclusion criteria: * type 2 diabetic inpatient * fasting glucose \>140 mg/dl or random glucose \>180 mg/dl exclusion criteria: * incooperative for glucose monitor * refusal of insulin * pregnancy

Keywords: type 2 diabetes inpatient glucose control continue glucose monitor
seeg investigation of mood dysregulation in epilepsy

Conditions: Epilepsy

Summary: using the novel analysis of stereo-electroencephalography (seeg) recordings, this proposal will investigate the activity and connectivity of mood regulation circuits in subjects with suspected epileptic focus who have undergone seeg electrode implantation for monitoring of seizure activity.

it is well known that epilepsy is associated with mood dysregulation including symptoms of labile mood, impulse control problems, anxiety, depression and increase in incidence of suicide. however, until present the neurobiological basis of mood dysregulation in epilepsy has not been clear and has been mostly attributed to a psychological reaction to the illness. this has severely limited our understanding of the impairments in mood regulation that people with epilepsy often experience and has also limited the development of effective treatment for ameliorating psychosocial dysfunction in people with epilepsy. the identification of these circuits will not only increase our understanding of mood-regulation in epilepsy but also possibly provide biomarkers with which the effectiveness of new treatments can be investigated. developing better diagnostic measures and treatments for mood dysregulation will be highly beneficial to the quality of life of subjects suffering from epilepsy.

Eligibility criteria:
inclusion criteria: * subjects will be a part of the epilepsy-monitoring unit for long-term seeg recordings and analysis exclusion criteria: * subjects that experience surgical complications during the implant procedure will be excluded from the study
dose response effects of marine omega-3 fatty acids on inflammation

Conditions: Cardiovascular Disease; Inflammation

Summary: the purpose of this study is to determine the lowest effective dose of epa + dha (300, 600, 900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the inflammatory response to in vivo and ex vivo endotoxin challenge as measured by the production over time of several inflammatory markers.

inflammation is an important biological process initiated by the immune system in response to injury, irritation or infection. prolonged or chronic inflammation is involved in the etiology of several diseases such as cardiovascular disease (cvd), diabetes, rheumatoid arthritis, cancer, and neurodegenerative diseases such as alzheimer disease. the evidence base clearly demonstrates benefits of diet in ameliorating inflammation and reducing the burden of chronic disease. with respect to marine-derived omega-3 fatty acids and various markers of inflammation related to cardiovascular disease (cvd), both population studies and randomized controlled supplementation trials have yielded mixed results. some studies have demonstrated a dose-response relationship between dietary eicosapentaenoic acid and docosahexaenoic acid (epa + dha) and increased membrane (phospholipid) epa and dha. red blood cell (rbc) epa + dha content has been proposed as a potential, modifiable marker for coronary heart disease (chd) risk. it is well established that these fatty acids are precursors of series-3 prostanoids, thromboxanes, 5-series leukotrienes, and novel lipid mediators such as resolvins and protectins that have anti-inflammatory effects. we hypothesize that nutritionally-relevant intakes of omega-3 fatty acids are able to blunt the usual response to an inflammatory stimulus. we propose to test this hypothesis using both in vivo (i.v. endotoxin challenge) and ex vivo (endotoxin-stimulated monocytes) models in a 6-month, dose-response study with marine-derived omega-3 fatty acid supplements in healthy volunteers.

Eligibility criteria:
inclusion criteria: * healthy men and non-pregnant/lactating women between the ages of 20 and 45 * bmi \>19.9 and \<30.0 * able to give written informed consent and willing to comply with all study- related procedures. exclusion criteria: * previous history of heart disease or diabetes * renal insufficiency * chronic anti-inflammatory use * systolic blood pressure \< 90 * individuals currently using tobacco products or have done so in the previous 30 days * individuals taking omega-3 fatty acid supplements or their usual intake of fish is greater than 3-4 servings per month.

Keywords: cardiovascular disease inflammation fish oil omega-3 fatty acids lps endotoxin
effect on the vitreous of the not complicated surgery of the cataract to the emmetropic patient

Conditions: Cataract; Vitreous Detachment

Summary: this study evaluates the association between surgery of the cataract and posterior vitreous detachment, in the emmetropic patient, by comparing eyes operated with eyes not operated in the same group of patients


Eligibility criteria:
inclusion criteria: * adult emmetropic patient * without complete posterior vitreus detachment in both eyes before having surgery. exclusion criteria: * diabetic retinopathy * ophthalmological treatment in progress * history of ophthalmological surgery
retrospective study on the use of immunotherapy in patients with msi-h metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: an increasing number of patients with metastatic colorectal cancer (mcrc) are able to receive 3 or more lines of therapy. in this setting, can be recognize treatments such as regorafenib (an oral multikinase inhibitor), trifluridine/tipiracil hydrochloride (tas-102), an antineoplastic nucleoside analogue, and antibodies anti-epidermal growth factor receptor (egfr) in patients with ras wild-type tumors (if no prior exposure to antibodies). maintaining quality of life is an essential goal for third- and later-line treatments for patients. the anti-programmed cell death protein 1 (anti-pd-1) immune checkpoint inhibitors, pembrolizumab and nivolumab, were approved in the us by the fda in 2017, and the combination nivolumab plus ipilimumab (anti ctla-4) was recently approved by the fda in 2018, all in the second and later-line setting for patients with microsatellite instability-high (msi-h) or deficient dna mismatch repair mcrc whose disease has progressed despite treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. at present, these agents are not approved in europe for mcrc patients with msi-h. clinical trial results and scientific data supported evidence that immunotherapies provide benefit but are limited to the small proportion (\< 5%) of patients with msi-h tumors, in whom they are highly effective. therefore, patients with msi-h disease should be referred as expeditiously as possible to receive immune checkpoint inhibitors. the aim the study is to retrospectively collect data of patients treated with immunotherapy in the context of real clinical practice, in order to describe the real impact in terms of clinical outcomes and tolerability of treatment in common clinical practice.


Eligibility criteria:
inclusion criteria: * signed informed consent for alive patients * patients with diagnosis of colorectal cancer with msi-h * patient treated with at least one administration of antibody anti pd-1 for colorectal cancer prior to 30 june 2020 outside clinical trials. * availability of the tumor tissue from the primary tumor or a metastatic site for molecular analyses. the availability of tumor tissue is recommended but not mandatory. exclusion criteria: * patients who received immunotherapy during a clinical trial.

Keywords: h-msi immunotherapy
prognostic value of sympathetic modulation in patients with heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to determine whether oscillatory pattern of sympathetic nerve activity muscle is an efficient index for the prognosis of patients with heart failure.


Eligibility criteria:
inclusion criteria: * patients with systolic heart failure and new york heart association (nyha) * ischemic, hypertensive, or idiopathic etiology * left ventricular ejection fraction less than 40% exclusion criteria: * neuromuscular, orthopedic, neurologic and pulmonary diseases * renal failure * diabetes mellitus type ii